A Study of the Combination of Multiple Doses of RO5285119 With a Single Dose of Risperidone in Healthy Volunteers
This study has been completed.
Sponsor:
Hoffmann-La Roche
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT01708616
First received: October 15, 2012
Last updated: May 7, 2013
Last verified: May 2013
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Purpose
This single-center, randomized, double-blind, two-period crossover study will evaluate the safety, tolerability, pharmacokinetics and pharmacodynamic effects of the combination of multiple doses of RO5285119 with a single dose of risperidone in healthy volunteers. Subjects will be randomized to one of 4 treatment sequences of two periods to receive multiple doses of RO5285119 plus a single dose of risperidone or risperidone placebo or multiple doses of RO5285119 placebo plus a single dose of risperidone or risperidone placebo, with a washout period of approximately 3 weeks between treatment periods. Anticipated time on study is up to 12 weeks (from screening through study completion).
| Condition | Intervention | Phase |
|---|---|---|
|
Healthy Volunteer |
Drug: RO5285119 Drug: risperidone Drug: RO5285119 placebo Drug: risperidone placebo |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Pharmacokinetics/Dynamics Study Intervention Model: Crossover Assignment Masking: Double Blind (Subject, Investigator) |
| Official Title: | A Single-center, Randomized, Double-blind, Two-period Crossover Study to Investigate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamic Effects of the Combination of Multiple Doses of RO5285119 With a Single Dose of Risperidone in Healthy Subjects |
Resource links provided by NLM:
Further study details as provided by Hoffmann-La Roche:
Primary Outcome Measures:
- Pharmacokinetics of single dose risperidone in combination with multiple doses of RO5285119: Maximum plasma concentration (Cmax) [ Time Frame: Pre-dose to 24 hours post-dose ] [ Designated as safety issue: No ]
- Pharmacokinetics of single dose risperidone in combination with multiple doses of RO5285119: Area under the concentration-time curve (AUC) [ Time Frame: Pre-dose to 24 hours post-dose ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Safety: Incidence of adverse events [ Time Frame: approximately 12 weeks ] [ Designated as safety issue: No ]
- Pharmacodynamic markers for risperidone: Prolactin levels [ Time Frame: Pre-dose to 6 hours post-dose ] [ Designated as safety issue: No ]
- Pharmacodynamic assessments for risperidone: Level of sedation [ Time Frame: Pre-dose to 24 hours post-dose ] [ Designated as safety issue: No ]
- Pharmacokinetics of RO5285119 in combination with single dose risperidone: Maximum plasma concentration (Cmax) [ Time Frame: Day 1 to Day 18 ] [ Designated as safety issue: No ]
- Pharmacokinetics of RO5285119 in combination with single dose risperidone: Area under the concentration-time curve (AUC) [ Time Frame: Day1 to Day 18 ] [ Designated as safety issue: No ]
| Enrollment: | 24 |
| Study Start Date: | November 2012 |
| Study Completion Date: | April 2013 |
| Primary Completion Date: | April 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: RO5285119 + risperidone |
Drug: RO5285119
multiple doses
Drug: risperidone
single dose
|
| Active Comparator: RO5285119 + placebo |
Drug: RO5285119
multiple doses
Drug: risperidone placebo
single dose
|
| Placebo Comparator: Placebo + risperidone |
Drug: risperidone
single dose
Drug: RO5285119 placebo
multiple doses
|
| Placebo Comparator: Placebo +placebo |
Drug: RO5285119 placebo
multiple doses
Drug: risperidone placebo
single dose
|
Eligibility| Ages Eligible for Study: | 18 Years to 50 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Criteria
Inclusion Criteria:
- Healthy male and female adults, 18 - 50 years of age inclusive Healthy status is defined by absence of evidence of any active or chronic disease following detailed medical and surgical history and a physical examination including vital signs, 12-lead ECG, hematology, blood chemistry, serology and urinalysis
- Body mass index (BMI) 18 to 30 kg/m2 inclusive
- Women have to be postmenopausal or surgically sterile
- Male subjects must use a barrier method of contraception for the duration of the study and for 3 months after last dosing
Exclusion Criteria:
- Suspicion of regular consumption of drug of abuse, or history of drug or alcohol abuse
- Positive for hepatitis B, hepatitis C or HIV infection
- History of clinically significant hypersensitivity or allergic reactions
- Disorders of the central nervous system, including psychiatric disorders, behavioural disturbances, cerebrovascular events, depression, bipolar disorder, migraine, Parkinson
- Regular smoker (>5 cigarettes, >3 pipe-fulls, >3 cigars per day)
Administration of an investigational drug or device within 3 months prior to first dosing
- Hypersensitivity to risperidone or any of its excipients
- Any other known contraindications to risperidone as stated in the SmPC
Contacts and Locations More Information
No publications provided
| Responsible Party: | Hoffmann-La Roche |
| ClinicalTrials.gov Identifier: | NCT01708616 History of Changes |
| Other Study ID Numbers: | BP28318, 2012-003231-31 |
| Study First Received: | October 15, 2012 |
| Last Updated: | May 7, 2013 |
| Health Authority: | France: Agence nationale de sécurité du médicament et des produits de santé (ANSM) |
Additional relevant MeSH terms:
|
Risperidone Serotonin Antagonists Serotonin Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Physiological Effects of Drugs Antipsychotic Agents |
Tranquilizing Agents Central Nervous System Depressants Central Nervous System Agents Therapeutic Uses Psychotropic Drugs Dopamine Antagonists Dopamine Agents |
ClinicalTrials.gov processed this record on May 22, 2013